FDA Grants Fast-Track Approval to Linvoseltamab-GCPT for Advanced Multiple Myeloma

On July 2, 2025, the FDA gave accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a targeted therapy that helps the immune system attack cancer cells. It is for adults with relapsed or hard-to-treat multiple myeloma who have already tried at least four other treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.

Efficacy was tested using LINKER-MM1 (NCT03761108), an open-label, multi-center multi-cohort trial, consisting of 80 patients who have received at least 4 prior lines of therapy and didn’t work for them. The efficacy evaluation was based on the objective response rate (ORR) assessed by a blinded independent review committee according to the International Myeloma Working Group criteria. The ORR reached 70% (95% CI: 59–80). Among responders, with a median follow-up of 11.3 months, the estimated duration of response (DOR) was 89% (95% CI: 77–95) at 9 months and 72% (95% CI: 54–84) at 12 months.

Linvoseltamab-gcpt’s prescribing information includes a Boxed Warning for neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious, potentially fatal cytokine release syndrome (CRS). At the recommended dosage, 46% of patients in the LINKER-MM1 trial experienced CRS, and 54% experienced neurologic toxicity, including ICANS. Less than 1% of patients experienced severe (Grade 3) CRS, whereas 8% of patients experienced Grade 3 or 4 neurologic toxicity.

Linvoseltamab-gcpt is only accessible via the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS) program because of these risks. The possibility of infections, neutropenia, liver toxicity, and harm to an unborn child are further cautions.

Learn more: FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma | FDA